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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Burrs (molding flash) on the cutter may tear the harvested vien
If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.
Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Lipemic interference failed to meet the performance specification listed within the IFU.
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Incorrect Laser Marking - Solera Awl Tip Tap
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.